A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery

November 14, 2025 updated by: Biotech Healthcare Holding Gmbh

A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens

To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40212
        • Recruiting
        • Internationale Innovative Ophthalmochirurgie GbR
        • Contact:
        • Principal Investigator:
          • Dr. Detlev Breyer, Cataract & Refractive Surgeon
        • Sub-Investigator:
          • Kristin Lena Arzt, MD, FEBO
      • Greven, North Rhine-Westphalia, Germany, 48268
        • Recruiting
        • Augentagesklinik
        • Contact:
          • Edda Clinical Study Coordinator, Optometrist
          • Phone Number: 0049 0800 3 100 900
        • Principal Investigator:
          • Dr. Karen Sophie Glandorf, MD
        • Sub-Investigator:
          • Elisabeth Bari-Kacik, Specialist Ophthalmologist
      • Rheine, North Rhine-Westphalia, Germany, 48429
        • Recruiting
        • Augentagesklinik
        • Contact:
        • Principal Investigator:
          • Dr. Florian Kretz, MD, FEBO
        • Sub-Investigator:
          • David Beckers, MD
        • Sub-Investigator:
          • Lena Beckers, MD
        • Sub-Investigator:
          • Jil-Catherine Große-Volksbeck, MD
        • Sub-Investigator:
          • Frauke Jürgens, Specialist Ophthalmologist
  • India
    • Karnatak
      • Bangalore, Karnatak, India, 560082
        • Not yet recruiting
        • Netradhama Superspeciality Eye Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Sri Ganesh, Cataract & Refractive Surgeon
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600018
        • Recruiting
        • Dr. Agarwal Eye Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Ashvin Agarwal, M.S. (Opthalmology)
  • Spain
    • Córdoba
      • Córdoba, Córdoba, Spain, 14012
        • Recruiting
        • Hospital Arruzafa
        • Contact:
        • Principal Investigator:
          • Antonio Cano Ortiz, Cataract & Refractive Surgeon
        • Sub-Investigator:
          • Alberto Villarubia Cuadrado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age of patient >21 Years
  2. Patient diagnosed with cataract.
  3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
  4. Calculated IOL power is within the range of investigational IOLs.
  5. Patient willing to sign inform consent form.
  6. Clear intraocular media other than cataract.
  7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.

Exclusion Criteria:

  1. Previous intraocular or corneal surgery.
  2. Traumatic cataract
  3. Pregnancy (as stated by patient) or lactation.
  4. Concurrent participation in another drug or device investigation.
  5. Irregular astigmatism.
  6. Patient receiving chlorquine treatment.
  7. Subjects with any systemic disease that could increase operative risk or confound the outcome.
  8. Active ocular disease in the operative eye other than cataract.
  9. Vulnerable subjects as defined in section 12.3.9.
  10. Corneal Astigmatism > 4.5 D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)
Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization
Device: Optiflex TRIO Intraocular Lens
The patients will be implanted with Optiflex TRIO IOL at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal Toric with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism
Active Comparator: AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)
Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization
Device: AcrySof® IQ PanOptix®
The patients will be implanted with AcrySof® IQ PanOptix® at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is diffractive trifocal with the anterior surface being aspheric and the posterior surface with a toric component. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular distance corrected intermediate visual acuity (BCIDVA)
Time Frame: 6 months
The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months postoperative, with a target of equivalency between the two IOLs.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Healthcare Holding Gmbh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTVCPL-TRITORIC-2019-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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